FDA Adverse Event
Injury
Summary report: N
ARTHROSCOPE
MDR report key: 2900242
·
Received January 7, 2013
Report
- Report Number
- 1030489-2013-00079
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 9, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- HRX
- PMA / PMN Number
- K981251
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) FOR A VERTEBRAL FRACTURE AT L1 DUE TO TRAUMA. IT WAS REPORTED THAT THE PATIENT DEVELOPED A RE-FRACTURE OF THE POSTERIOR WALL AT L1 SOMETIME POST-OPERATIVELY. IN ADDITION, THE SPINAL CORD WAS REPORTEDLY COMPRESSED AND CAUSED PARALYSIS. A SECOND SURGERY WAS PERFORMED VIA LAMINECTOMY WITH INSTRUMENTATION OF SCREWS. NO OTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6481 | ARTHROSCOPE | HRX | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Required Intervention |